Radiofrequency Ablation Study in LatinX Patients

Part of paid clinical trials in New York, New York.

Sponsor
Northwell Health
Study ID
NCT05903196
Status
Recruiting
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Conditions

  • Thyroid Nodule

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Mygen V-1000 RF system — DEVICE
    The Mygen V-1000, a microprocessor-based generator of RF Medical Co., Ltd., provides up to 140 watts of radio-frequency (RF) energy to be used for coagulation \& ablation of vessel, tissue \& bone

Study Details

Benign thyroid nodules can still create cosmetic, compressive, or hormonal issues for patients. In the past, surgery was typically used to treat thyroid nodules causing the above issues through partial or complete thyroidectomy. More recently, minimally-invasive techniques have been developed to treat these issues. This study is investigating the use of one of these techniques, radiofrequency ablation, in Latinx patients with benign symptomatic thyroid nodules. This procedure is of interest because it avoids the risks of surgery and can be done outside an operating room. The study hypothesis is that the use of RFA is an effective and safe therapeutic option for LatinX patients with a symptomatic benign nodule wishing to avoid surgery.

Key Dates

Start date
Mar 12, 2024
Status verified
Sep 2025
Primary completion
Dec 1, 2025
Completion
Dec 30, 2025

Study Design

Enrollment
44 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Mygen V-1000 RF system
    The Mygen V-1000, a microprocessor-based generator of RF Medical Co., Ltd., provides up to 140 watts of radio-frequency (RF) energy to be used for coagulation \& ablation of vessel, tissue \& bone

Primary Outcome Measure

Number of participants with treatment-related changes in thyroid nodule volumes [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwell Health Physician PartnersNew YorkNew York10022
Karina Ziskovich, BBA
[email protected]
212-434-3715
Jose Sanchez Escobar, MD
[email protected]
212-434-4972

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By research site
Northwell Health Physician Partners· New York, NY

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